Bioequivalence and Bioavailability Forum

Representative batches? [Regulatives / Guidelines]

posted by Helmut  – Vienna, Austria, 2010-08-05 01:42 (4801 d 05:33 ago) – Posting: # 5719
Views: 14,912

Dear ElMaestro,

nice summary; couldn’t agree more.
Section 4.1.2 of the BE-GL: “representative” appears three times and “justify/justification” five times.

In the past sponsors tried to select T & R batches which matched closely in vitro (content & dissolution). If BE could be demonstrated, everybody was happy (believing that the “selection” worked). If not, most people did rather not question the (lacking) discriminatory power of the in vitro method, but sighed and said “Well, we have to face that it did not work in in vivo – but it’s well known, that without IVIVC, etc. etc.”

I have strong doubts that it is possible to justify that a batch is representative – if we move away from pharmaceutical quality and start thinking about BE.

---

I changed the category; doesn’t look as a statistical issue to me (any more). [Helmut]

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Helmut Schütz


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Science Quotes

Complete thread:

• inter-batch variability? Dr_Dan 2010-08-04 10:29 [Regulatives / Guidelines] 
  • inter-batch variability? Pavidus 2010-08-04 11:57
  • inter-batch variability? d_labes 2010-08-04 13:58
  • inter-batch variability? ElMaestro 2010-08-04 17:09
    • Between study variability common for HVDs Helmut 2010-08-04 19:45
      • Between study variability common for HVDs ElMaestro 2010-08-04 21:01
        • Representative batches?Helmut 2010-08-04 23:42
          • Representative batches? ElMaestro 2010-08-05 08:40
            • Representative batches? Helmut 2010-08-05 12:30
          • Representative batches? Dr_Dan 2010-08-05 08:58
            • Representative batches? Helmut 2010-08-05 12:45
              • Confidence intervals vs. point estimators Dr_Dan 2010-08-06 09:55
                • Confidence intervals vs. point estimators ElMaestro 2010-08-06 12:34
                  • Confidence intervals vs. point estimates Helmut 2010-08-06 13:20
                  • Confidence intervals vs. point estimators Dr_Dan 2010-08-06 14:44
                    • Confidence intervals vs. point estimators ElMaestro 2010-08-06 15:01
                      • meta analysis? martin 2010-08-06 17:25
                        • meta analysis? ElMaestro 2010-08-06 17:57
                          • meta analysis? Helmut 2010-08-06 18:31
                        • meta analysis? Ohlbe 2010-08-06 23:21
                          • No chance against RMS? Dr_Dan 2010-08-10 12:27
                            • No chance against RMS? ElMaestro 2010-08-10 16:26
    • Batch-to-Batch Pharmacokinetic Variability kumarnaidu 2016-07-20 07:16
      • tlast (Common) Helmut 2016-07-20 10:48
        • tlast (Common) nobody 2019-02-21 15:20
          • tlast (Common) ElMaestro 2019-02-21 16:32
            • tlast (Common) nobody 2019-02-21 17:02
              • tlast (Common) ElMaestro 2019-02-21 18:02
                • tlast (Common) nobody 2019-02-21 18:17